Identification of Clinically Insignificant or Significant Prostate Cancer With the miR Scientific Sentinel™ Platform

NCT04100811 | Unknown DMC

• 1 other identifier: MIR-P001
• Study Type: observational
• Target: 2,019
• Locations: 1 country
• Sites: 3

Brief Summary

In this non-interventional study, men being seen by urologists in the course of their normal practice that present with clinical suspicion of prostate cancer (based on DRE, elevated Prostate Specific Antigen (PSA), and/or family medical history of prostate cancer, among other reasons) and who meet the inclusion/exclusion criteria will be asked to consent to the clinical study and provide a 40-60 mL urine sample, without prior DRE, along with relevant de-identified clinical data, at the time of the initial consultation, prior to core-needle biopsy. The miR Scientific Sentinel® Prostate Cancer Classifier Platform (Sentinel® PCC4 Test) is a new molecular test that interrogates 442 small non-coding RNAs (sncRNA) extracted from urinary exosomes. Using the expression levels of 442 sncRNAs isolated from urine exosomes, the Sentinel® PCC4 Test provides an initial classification of disease status as either no molecular evidence of prostate cancer (NMEPC), or molecular evidence (MEPC) of low-, intermediate- or high-risk of aggressive prostate cancer. This study is designed to validate the classification algorithm and finalize the performance characteristics of the Test using risk-group labeling based on pathological grading from core-needle biopsy data.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Validate the performance characteristics of the miR Sentinel® PCC4 Test to classify subjects into low-risk, intermediate-risk, high-risk, or no molecular evidence of prostate cancer using risk-group labeling based on pathological grading

  The Sentinel® PCC4 Test is a urine exosome-based test that provides a molecular assessment of prostate cancer risk, for the diagnosis and prognosis that can be used for the management of prostate cancer. The test measures the levels of 442 small non-coding RNAs (sncRNAs) that include a mix of microRNAs (miRNAs) and small nucleolar RNA (snoRNAs). Because the false-negative rate of core-needle biopsy is generally thought to be in the range of at least 10-15%, the maximum achievable apparent specificity for diagnosing prostate cancer when using core needle biopsy pathology as the basis to assess prostate health may be at most 85-90%. We expect that with 1500 subjects enrolled, 630 (42%) will be biopsy negative with no pathological evidence of prostate cancer (NPEPC); 420 (28%) will be GG1; 195 (13%) will be GG2 and 255 (17%) will be GG3-GG5.

  Urine samples will be collected from participants at the time of entry and processed within 72 hours upon receipt for the miR Sentinel PCC4 Assay interrogation.

Secondary Outcomes (1)

• Validate the performance characteristics of the miR Sentinel® PCC4 Test to classify subjects into low-risk, intermediate-risk, high-risk, or no molecular evidence of prostate cancer using risk-group labeling based on NCCN risk assessment

  Urine samples will be collected from participants at the time of entry and processed within 72 hours upon receipt for the miR Sentinel PCC4 Assay interrogation.

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Only males get prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 4000 male participants will be enrolled from multi clinical sites in the U.S. and Canada. Participants will be men ages 45 and above with a core needle biopsy as part of routine clinical workup for diagnosis of prostate cancer.

You may qualify if:

• Males ≥ 45 years old
• Males with clinical suspicion of prostate cancer, including but not limited to elevated PSA level, suspicious DRE, family history of prostate cancer, and/or germline mutation, who as a result undergo TRUS- or MRI-guided core-needle biopsy and PSA recording (for NCCN group label).
• Signed informed consent prior to initiation of any study-related procedures.
• The patient provided a voided urine sample within 30 days prior to biopsy being performed and prior to DRE (if any). This collection must be ≥ 1 hour after the last urination.

You may not qualify if:

• Persons previously diagnosed with prostate cancer.
• Persons who have previously undergone a 12 core or fusion biopsy in the last 12 months
• Persons who have had a DRE within 72 hours of the urine collection
• Persons incapable of providing informed consent.
• Persons presenting with clinical symptoms of urinary tract infection, including prostatitis at the time of enrollment.
• Persons with prior history of invasive treatment for benign prostatic hyperplasia within 3-6 months of study enrollment.
• Patients treated with a 5-alpha-reductase inhibitor, Saw Palmetto for BPH or male pattern baldness within 3 months of the urine collection.

Sponsors & Collaborators

• miR Scientific LLC: lead

Study Sites (3)

Georgia Urology

Atlanta, Georgia, 30328, United States

Location

Urology of Greater Atlanta

Stockbridge, Georgia, 30281, United States

Location

Integrated Medical Professionals

Farmingdale, New York, 11735, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine for Sentinel™ PCC4 Assay

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Carl A Olsson, MD

  Integrated Medical Professionals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 24, 2019
• Study Start: December 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

US (3)